In the field of medicine, imaging and image guidance tends to be a significant component of clinical care. From diagnosis and monitoring of disease, to planning of the surgical approach, to guidance during procedures and follow-up after the procedure is complete, imaging and image guidance provides effective and multifaceted treatment approaches, for a variety of procedures, including surgery and radiation therapy.
Targeted stem cell delivery, adaptive chemotherapy regimens, and radiation therapy are only a few examples of procedures utilizing imaging guidance in the medical field.
Advanced imaging modalities such as Magnetic Resonance Imaging (“MRI”) have led to improved rates and accuracy of detection, diagnosis and staging in several fields of medicine including neurology, where imaging of diseases such as brain cancer, stroke, Intra-Cerebral Hemorrhage (“ICH”), and neurodegenerative diseases, such as Parkinson's and Alzheimer's, are performed. As an imaging modality, MRI tends to enable three-dimensional visualization of tissue with high contrast in soft tissue without the use of ionizing radiation. This modality is often used in conjunction with other modalities such as Ultrasound (“US”), Positron Emission Tomography (“PET”) and Computed X-ray Tomography (“CT”), by examining the same tissue using different physical principals available with each modality.
CT is often used to visualize boney structures, and blood vessels when used in conjunction with an intra-venous agent such as an iodinated contrast agent. MRI may also be performed using a similar contrast agent, such as an intra-venous gadolinium based contrast agent which has pharmaco-kinetic properties that enable visualization of tumors, and break-down of the blood brain barrier.
These multi-modality solutions may provide varying degrees of contrast between different tissue types, tissue function, and disease states. Imaging modalities can be used in isolation, or in combination to better differentiate and diagnose disease.
In neurosurgery, for example, brain tumors are typically excised through an open craniotomy approach guided by imaging. The data collected in these solutions typically consists of CT scans with associated contrast, such as iodinated contrast, as well as MRI scans with associated contrast, such as gadolinium contrast. Also, optical imaging is often used in the form of a microscope to differentiate the boundaries of the tumor from healthy tissue, known as the peripheral zone. Tracking of instruments relative to the patient and the associated imaging data is also often achieved by way of external hardware systems such as mechanical arms, or radiofrequency or optical tracking devices. As a set, these devices are commonly referred to as surgical navigation systems.
Previously known systems for multi-modality imaging for planning and navigation include integration of the imaging data of the surgery suite in an operating room. Technologies have allowed these three-dimensional modalities, including PET, CT, MRI, 3D US and two-dimensional modalities such as X-ray and US, to be viewed together to create image sets, used in the operating room. These image sets can be used to assist surgeons in better resecting diseased tissue such as cancer, to guide repair of vascular defects such as stroke and ICH, to deliver therapies for psychiatric conditions such as major depression or obsessive compulsive disorder, to perform procedures such as deep brain stimulation (“DBS”) for Parkinson's, Alzheimer's and Huntington's, and to guide radiation oncologists for radiation therapy for brain tumors.
These solutions have attempted to integrate different imaging modalities into the surgical suite, by use of intra-operative imaging; for example by registering and tracking real-time US images; by use of “C” shaped arms for X-ray or CT imaging (“C-arms”); for instance, by use of dedicated MRI systems for specific parts of the anatomy, such as the head; as well as use of movable MRI systems. Generally, these systems do not take full advantage of the ability to achieve better imaging with the improved access afforded by the surgical procedure itself, nor is the information acquired integrated into the procedure in ways that address the fundamental challenges associated with the disease management.
There is therefore a need for a multi-modality imaging system and method that achieves surgical planning and navigation by analyzing input(s) retrieved through the improved tissue access resulting from the surgical procedures themselves.
Furthermore, there is a need for effective recording registration or integrating images and other inputs in a meaningful way. Additionally, there is a need to integrate other valuable data points related to surgical tools, or physics of the tissues themselves. There is therefore a need for a multi-modality imaging system and method that achieves surgical planning and navigation by meaningfully integrating a number of data points retrieved during, before and after surgery to provide improved surgical and navigation systems. There is also a need for a system and method that utilizes information specific to the surgical procedure and tools to provide improved navigation and planning.
Furthermore, imaging in current solutions is often performed on large sections of tissue, such as brain tissue, accessed by open surgical approaches that are highly invasive to the patient. There is also a growing class of procedures, including neurosurgical procedures, which ideally would require only minimally invasive navigation and imaging system approaches. For example, ICH repair, stroke repair, deep brain tumor surgery, intra-axial brain tumor surgery, endo-nasal surgery, such as pituitary or brain-stem surgery, stem-cell therapy, directed drug delivery, and deep brain stimulator delivery are all examples of procedures that are well suited to minimally invasive approaches. Many surgical approaches in neurosurgery have become more dependent on minimally invasive approaches to resect diseased tissue, modify vascular and clotting issues, and maintain as much healthy neural tissue as possible. Current intra-operative surgical systems such as navigation and imaging solutions, however, tend to be lacking. Although approaches to remove tissue through endo-nasal approaches, access port-based approaches, and positioning of electrical stimulation devices have become important procedures, medical imaging and navigation procedures have not evolved to accommodate the specific needs of these approaches.
There is therefore a need for a multi-modality imaging system and method that achieves surgical planning and navigation through minimally invasive means and approaches.
Also, as port based procedures are relatively new, the detailed application of imaging to such a procedure has not been anticipated, nor has the interface between known devices' impact on tissue been integrated into a planning system. In craniotomies, the complexity of the multiple contrast mechanisms used in known systems can overwhelm software system architectures. Furthermore, the complexities associated with tissue shift that occurs during surgery are not well addressed. There is therefore a need for a system and method for pre-operative and intra-operative planning and navigation to allow for minimally invasive port based surgical procedures, as well as larger, open craniotomies.
In current systems, a radiologist, neurologist, surgeon or other medical professional normally selects an imaging volume based on diagnostic imaging information, or clinical information related to the patient. This imaging volume is often associated with a suggested trajectory to approach the surgery, for instance a needle insertion path. One disadvantage of current systems, however, is that this information regarding tumor location and trajectory can typically not be modified or interacted with in the surgical suite, resulting in limited utility of this detailed information if additional information during the surgery comes to light, for instance the location of a vessel or critical structure in conflict with the pre-selected trajectory. There is therefore a need for a system that provides real-time surgical procedure planning correction.